Our dedicated staff is composed of sixteen (16) full time research members. We pride ourselves on precision, accuracy and timeliness in protocol completion. The Quality Assurance management is organized to optimize the quality of our research. The Clinical Research Director, who is a licensed Nurse Practitioner, ensures that the patients are being managed correctly from a protocol and medical standpoint. Protocol adherence is overseen and follow up on all medical issues with the principal investigator is our standard on all protocols.
The coordinators are comprised of Certified Clinical Research Coordinators (CCRC’s) and Data Research Coordinators (DRC’s). The CCRC’s have been well trained in clinical research with an average experience of more than 10 years. They are responsible for conducting protocol required patient visits, collecting and documenting clinical information as well as making sure that protocol integrity is upheld to the highest of standards.
The CCRC’s attend sponsor product protocol training meetings and in turn relay this information back to the entire clinical staff in regular staff protocol training sessions.
The DRC’s maintain regulatory files and transfer source documentation to Case Report Forms (CRF’s) after each study visit is completed. They also perform quality assessments regularly and review all Case Report Forms before each monitoring visit ensuring that all data is complete and meets the Sponsor’s and FDA’s standards. Because the Data Research Coordinators do not see patients clinically, they are very accessible to the monitors during their site monitoring visits to help meet the monitor’s visit goals more efficiently.
Our Recruitment Specialist Team strategically places print, radio, television and internet ad campaigns to meet maximum patient recruitment. Other methods of patient enrollment include: patient mailings, in-office brochure/flyer distribution and telephone screening. Our local Physician Referral program also plays a large role in the recruitment process.
Our experience of conducting over 350 clinical trials provides us with a generous data base of prior study volunteers.
Belinda Peters, ARNP-C Nurse Practitioner
|Staff||Years of Research & Medical Experience|
|Sayonara Nunez, CCRC
Certified Clinical Research Coordinator
|14 yrs of Research|
Clinical Research Coordinator
|11 yrs of Research|
|Deborah L. Shannon, CCRC
Data Research Coordinator
|12 yrs of Research|
|Phillippa McCartney, RMA, CPT
Medical Assistant / Clinical Research Coordinator
|4 yrs of Research|
Patient Recruitment Manager
|11 yrs of Research|
|Phyllis Kahn, ARNP-C
|6 months of Research|
|Amy Gittelman, MS,ARNP, BC, CCRC
Clinical Research Director
|10 yrs of Research|